Pfizer Investigational Site
Madison, Wisconsin, 53704, United States
NCT Number: NCT02110342
The study aims to understand, using radiolabelled PF-04449913, how this compound is modified by the body once it is absorbed. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Madison, Wisconsin, 53704, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single oral dose of 100 mg PF-04449913 + 100µCi of [14C] PF-04449913
Time frame: 7 days
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Time frame: 7 days
Time frame: 7 days
AUC (0 - 8)= Area under the plasma radioactivity concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Time frame: 7 days
Time frame: 7 days
Total percentage of dosed radioactivity recovered in urine and feces
Time frame: 7 days
Total percentage of radioactivity in blood related to drug product
Time frame: 7 days
Measure of renal clearance (CLr), amount excreted unchanged in urine (Ae) and the fraction of dose excreted unchanged in urine (AE%)
Time frame: 7 days
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 7 days
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 7 days
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: 7 days
plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Pfizer
Industry
A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] PF-04449913 In Healthy Male Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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